Assuring patient safety is difficult when clinical work is unpredictable and fast paced, or when urgent interventions necessitate rapid clinical assessments, clear and effective communication, and quick action. Clinicians may need to question other practitioners at the bedside when they do not understand the diagnosis or treatment, disagree with patient care actions or plans, or have other patient safety concerns. Although it may be intuitive that appropriate questioning has potential to improve patient safety and foster a healthy learning environment, research in several fields such as applied psychology, organizational behavior, aviation, and healthcare suggests that it is difficult to ask questions, express disagreement, or challenge the actions of “superiors.”1–10
Human factors and teamwork failures in the airline industry before the mid-1970s led to the genesis of “Cockpit Resource Management” training, in part, to encourage cockpit crews to “speak up” when safety concerns arose.11,12 Using many of the principles espoused in the airline training system, Gaba et al developed an analogous program referred to as Crisis Resource Management in a medical specialty, specifically anesthesiology, to address some of the same concerns.13,14 On the basis of this previous work, we have developed Crisis Resource Management programs in other disciplines such as emergency medicine, radiology, and obstetrics involving clinicians with various experience levels that routinely address issues of challenging potentially wrong or unsafe decisions when patient safety concerns arise.15–19
When issues around challenging authority arise during debriefing discussions, our course participants (anesthesiology residents) often describe perceived barriers to action, including (1) assumed hierarchy, (2) fear of embarrassment of self or others, (3) concern over being misjudged, (4) fear of being wrong, (5) fear of retribution, (6) jeopardizing an ongoing relationship, (7) natural avoidance of conflict, and (8) concern for reputation. When these discussions involve the situation of a student challenging a teacher or a mentor, the related issues of (1) respect for the teacher/student relationship, (2) violation of a special trust, (3) high value placed on experience, and (4) concern over being negatively evaluated are often cited. In addition to the psychosocial constraints, our course participants report that not finding the appropriate words or phrasing inhibits their ability to challenge a decision when a concern over patient safety arises.
In response to our own observations and the organizational behavior research base,3–9 we developed an intervention that espouses the “two-challenge rule” (with roots in the aviation industry) to support the notion that all members of the team, even subordinates, share responsibility for a safe outcome and are obligated to speak up (even repeatedly) when actions do not seem right.20,21 In US Army aviation, for example, the rule is described as follows: “The two-challenge rule allows one crew member to automatically assume the duties of another crew member who fails to respond to two consecutive challenges. For example, the pilot-on-the-controls becomes fixated, confused, task overloaded or otherwise allows the aircraft to enter an unsafe position or attitude. The pilot-not-on-the-controls first asks the pilot-on-the-controls if he is aware of the aircraft position or attitude. If the pilot-on-the-controls does not acknowledge this challenge, the pilot-not-on-the-controls issues a second challenge. If the pilot-on-the-controls fails to acknowledge the second challenge, the pilot-not-on-the-controls assumes control of the aircraft.”22 The concept of the two-challenge rule was first transitioned to healthcare in the MedTeams program and the Air Force’s Medical Team Management program.23
To provide a method of implementing the two-challenge rule that was more culturally sensitive to the healthcare setting, we built on findings from organizational behavior that used collaborative conversational techniques. We focused on two major patterns of conversation typically seen in organizations. One pattern, known as “Model I” or “Mystery-Mastery” is characterized by keeping one’s reasoning hidden, seeking to appear rational, suppressing negative emotion, and seeking to achieve one’s own ends unilaterally. This approach is associated with limited organizational learning, political coalitions, and poorer strategy development.5,24–28 The second, much rarer approach, known as “Model II” or “Collaborative Inquiry” is characterized by public testing of conclusions and reasoning, inquiry into alternative points of view, and seeking to enhance free and informed choice.5,29,30 Pairing advocacy with inquiry is part of a conversational process that enacts a Model II or collaborative inquiry approach.
To maximize the receptiveness of the person being questioned, and to minimize defensiveness, we borrowed this approach from the discipline of organizational behavior. Specifically, we teach “pairing advocacy and inquiry.”27,30–33 Advocacy is a statement that describes the trainee’s opinion or position and inquiry is a question, usually in the form of a genuinely curious request for the other person’s thoughts. Making one’s thinking “visible” or “public” and inviting others to share their thoughts has been shown to surface valid information, and trigger self-correcting dialog.3,5
The two-challenge approach was implemented via twice pairing an advocacy-inquiry and then taking some action. For instance, “I see that you plan to administer a spinal anesthetic to this patient. She has a platelet count of 80,000. I learned that we shouldn’t do a spinal unless the count was at least 100,000. Can you clarify your view?” If no answer or a nonsensical answer is received from the attending faculty anesthesiologist, the trainee might say, “I see that you plan to administer a spinal anesthetic, but I worry her platelets are too low. I think it’s unsafe and we should do a general anesthetic. What do you think?” Again, if no answer or a nonsensical answer is forthcoming, the trainee is taught to get additional help to protect the patient and resolve the disagreement. We sought to determine whether the conversational technique of pairing advocacy and inquiry could be learned by anesthesiology residents and applied to acute clinical situations where “speaking up” was indicated.
After institutional review board approval of the protocol, 40 anesthesia trainees (first year 30%, second year 45%, third, or fourth year 25%) were recruited from hospital residency and fellowship programs affiliated with Harvard Medical School. The trainees were selected based on their availability during a month-long obstetric anesthesia rotation or a month-long simulation elective. All anesthesiology residents in the Harvard Medical School programs have had previous experience with simulation of anesthesiology cases. In obtaining consent, the trainees were told that they would be participating in two clinical case scenarios that would give them opportunities to practice management of obstetric emergencies and also to improve teamwork skills. Two simulated cases (Case A and Case B) were constructed in which three clinical problems were presented to the trainees in a fully simulated operating room. Each clinical problem presented an opportunity for the trainee to challenge another clinician regarding a relatively contraindicated request, action, or behavior. The scenarios included potential challenges to the resident’s attending faculty anesthesiologist (C1), an attending faculty surgeon (C2), and circulating nurse (C3) who were all confederates. Cases A and B were presented in random order to residents with a 30 to 45-minute educational intervention (debriefing) between the two cases. The actors and debriefers were experienced staff members from the Center for Medical Simulation, older than the subjects, and generally not well known to them. The same individuals played the same roles throughout. The attending anesthesiologist was male, the surgeon was female, and the circulating nurse was male. The debriefings were conducted by one of two senior educators and one physician who were trained in debriefing techniques, the two-challenge rule, and advocacy-inquiry techniques. Thus, there was a high degree of consistency in the scenarios and discussions.
A 30-year-old woman G3, P2, who presented to the operating room for an emergency cesarean delivery for a suspected placental abruption. The subject was brought into the operating room by the clinical director and introduced to the staff anesthesiologist who was preparing to induce the patient for a general anesthetic. The staff anesthesiologist stated to the subject that he was glad for his or her help, gave the briefest possible history, and asked whether the subject would administer the medications (propofol and succinylcholine) and apply cricoid pressure while the staff would perform the tracheal intubation. The obstetrician was urging utmost speed as the fetal heart rate had fallen and she was concerned about the viability of the fetus. Medications for the case were neatly arranged in prefilled labeled syringes, as is the custom in all scenarios at this simulation center. The subject was to notice that the succinylcholine syringe contained less than 1 mL (10 mg) of medication and there was no other supply immediately visible. When told that there was inadequate muscle relaxant, the staff anesthesiologist said, “OK. Grab that laryngeal mask airway, hand it to me, and let’s get going with the propofol.” Before the subject could respond, the circulating nurse, overhearing the problem of inadequate succinylcholine, said, “You need sux? I can go out and get some. It will take me a few seconds.” This was the first challenge opportunity (C1) in which the trainee could speak up about the merits of securing the patient’s airway properly with a tracheal tube, rather than with an laryngeal mask airway. Regardless of whether the subject challenged, the circulating nurse returned with succinylcholine in time for the anesthesia team to perform a rapid sequence induction and place a tracheal tube. The induction proceeded without complication and the cesarean delivery was begun. The patient’s vital signs were notable for hypertension and tachycardia (heart rate = 110). The staff explained that the patient was a cocaine abuser and that the vital signs were expected and left the room when he was paged to assist with another case. After a few minutes, the newborn was delivered, cared for by a pediatrician, and taken to the nursery. The surgeon then complained of excessive blood loss, and a boggy uterus and asked the subject in an insistent manner, “This is still bleeding. Quick, give 200 mcgs of methergine IV.” As methylergonovine is usually contraindicated in a hypertensive, cocaine-abusing patient and almost never given intravenously because of the potential for catastrophic hypertension, this was the second challenge opportunity (C2). Regardless of the subject’s response, after a short time, the bleeding abated and the patient became cardiovascularly stable. At this point, the circulating nurse came into the room, stood next to the subject and said in a loud voice to the obstetrician, “I have the dad out there and he is chomping at the bit to come in here and see his wife. Is it ok with you?” The obstetrician shrugged her shoulders and said, “Whatever you want to do.” As having a father be present during a general anesthetic is highly unusual and potentially distracting to the care team, this was the third challenge opportunity (C3).
A 29-year-old woman G3, P2 who presented to the operating room for an urgent cesarean delivery for breech presentation in labor. The subject was brought into the operating room by the clinical director and introduced to the staff anesthesiologist who was preparing the patient for a spinal anesthetic. A spinal tray, sterile gloves, and the patient’s history sheet were on a cart near the subject. The staff anesthesiologist welcomed the subject, introduced him or her to the patient, and asked that he or she check the labs and prepare to place the spinal anesthetic. The platelet count on the laboratory sheet read 80,000 thrombocytes per microliter. This was the first challenge opportunity (C1). If the subject questioned performing a spinal anesthetic in the setting of a relatively low platelet count, the staff anesthesiologist vaguely replied, “That’s OK. Let’s get going with the spinal.” If the subject challenged again, the response was, “Come on, we need to get going.” Regardless of whether the subject challenged, the circulating nurse then reported that the laboratory had called with new values and the platelet count was now 50,000 thrombocytes per microliter. This new information prompted the staff anesthesiologist to decide to change the plan and administer a general anesthetic. The induction proceeded uneventfully and the attending anesthesiologist left the room to take care of another patient. After a suitable period, the obstetrician asked the circulating nurse to get some methylene blue dye as she may have made a small perforation in the bladder. Simultaneously, the patient’s cardiac rhythm changed to an unexpected supraventricular tachycardia with a rate of 140 and systolic blood pressure dropped to 90 mm Hg. The circulating nurse announced out loud to the room that he was leaving to get methylene blue at the pharmacy and would not be back for 10 minutes or so. This was the second challenge opportunity (C2) for the trainee, who might argue that in the setting of patient instability, the nurse should stay in the room and that other personnel could be called to deliver the methylene blue. Regardless of whether the subject challenged the circulating nurse about leaving the room, the supraventricular tachycardia resolved and the vital signs returned to normal. If the subject had called for help from his/her attending, the staff anesthesiologist returned, reviewed the possible causes of the sudden supraventricular tachycardia with the subject and, as the vital signs were normal and the surgery almost complete, then left to go back to another case. After a suitable period of normalcy, the obstetrician asked the circulating nurse to get the “study drug” out of her briefcase. She then asked the subject whether he/she would please give an intravenous dose of a study drug from the syringe labeled “study drug no. 15.” The obstetrician explained that she was doing a study on adhesions from endometriosis and was comparing the effects of steroids with saline on subsequent adhesion formation. She suggested that it was in this patient’s best interest as if she received the steroid, it might help her thrombocytopenia and if it were saline it would not harm her. She then added that she would get consent from the patient after the surgery. This was the third challenge opportunity (C3) where the subject could address the lack of informed consent.
Debriefing sessions followed a four-step process. After a reactions phase in which trainees could spontaneously share their most pressing concerns we moved to a second, understanding phase. This phase was designed to promote self-reflection about why they did or did not speak up with a specific emphasis on surfacing and discussing trainees’ assumptions and concerns regarding challenging authority, after a procedure described by Rudolph et al.34 The debriefers took notes of the debriefing conversation to be able to characterize the subjects’ views. We then moved to a third, didactic, and discussion phase, which included discussion of trainees’ personal experiences with real-life situations in the past where they may have felt the need to challenge a superior. The instructors introduced the concepts of shared responsibility for safety and the obligation to speak up, as exemplified by the two-challenge rule. In the fourth phase, instructors demonstrated the “advocacy-inquiry” communication approach and residents were given an opportunity to practice the approach. They formulated and verbalized advocacy plus inquiry statements that could have been used during the situations experienced in the first scenario. Working in brief 2 to 3-minute cycles of experimenting and receiving feedback from instructors, the trainees were able to practice the unfamiliar phrasing in a safe, structured environment. The trainees were then told that they would have additional opportunities, during a second scenario, to practice and reinforce the use of the two-challenge rule using advocacy-inquiry and then calling for help.
Each video-recorded scenario was viewed and coded independently by two investigator anesthesiologists who were blind to whether they were watching a pre- or postintervention scenario. All differences in scoring were resolved by the reviewers during a third (joint) assessment. The trainee’s language was coded based on the criteria summarized in Table 1 (nothing, oblique statement, advocacy, and/or inquiry). We compared trainee performance before and after debriefing and instruction in the “two-challenge” and “advocacy-inquiry” approaches and assessed the degree of improvement of challenges made by trainees toward the attending faculty anesthesiologist, attending faculty surgeon, and circulating nurse. Scores after debriefing and instruction were compared with those before using the Wilcoxon signed-rank test with P < 0.05 considered significant.
Video data was complete from 36 (90%) participants (both scenarios, with six potential opportunities for challenging, were recorded fully for subsequent retrieval and analysis). In three instances, archived video was incomplete and could not be scored. In a fourth instance, scoring could not be carried out on two of the three challenge opportunities of a second scenario because the resident challenged so forcefully and adamantly at the first opportunity (to cancel the case) that the simulated case could not be completed.
As shown in Figure 1, there was an increased frequency of the use of advocacy and inquiry by trainees after debriefing. The use of crisp advocacy-inquiry language, or the ability to foster discussion through repetitive advocacy or inquiry occurred 27% of the time pretraining and 65% of the time after training. Table 2 summarizes how the debriefing intervention affected challenges specifically directed toward individual OR team members: the anesthesiology attending, obstetric surgeon and circulating nurse. Expressed scores are means ± standard deviations.
As shown in Figure 2, there was an improvement in the quality of challenges verbalized toward attending faculty anesthesiologists. Trainees used paired advocacy-inquiry language, or successfully initiated discussion through repetitive advocacy or inquiry 16% of the time pretraining, and 72% of the time after training. Analysis of the individual performances of each trainee yielded statistically significant improvements in challenging the anesthesiology attending (P = 0.0004).
The quality of challenges directed toward attending faculty surgeons was also improved. As shown in Figure 3, the use of paired advocacy-inquiry language or repetitive advocacy or inquiry increased from 29% pretraining to 67% postdebriefing. Analysis of the individual performances of each trainee yielded statistically significant improvements in challenging the obstetrician (P = 0.002).
In contrast to the challenges verbalized by trainees toward superordinate physicians, the challenges verbalized toward nurses were not improved overall (P = 0.84). Figure 4 shows the ineffectiveness of the intervention on the quality of challenges.
Although learning from readings and lectures is invaluable, much of the art and practice of medicine is learned at the patient’s bedside. Clinical decisions and interventions made by trainees directly impact on the safety and wellbeing of the patients. Human errors negatively impact patient outcomes and are exacerbated in a clinical environment characterized by unpredictability, high stakes, and time stress.35,36 Particularly during emergency procedures, or when there is an acute decline in patient stability, urgent interventions necessitate rapid clinical assessments and effective communication between clinicians.
We have demonstrated that a two-pronged educational intervention aimed at improving the quality and effectiveness of “speaking up” across authority gradients in the simulated operating room can be learned and applied by anesthesiology residents.
Even in the setting of simulated obstetric emergencies, many participants were able to retrieve and use these enhanced skills as demonstrated by improved scores after training. In particular, the quality of challenges directed toward superordinate physicians (anesthesiology and surgery attending faculty) was improved. That this has direct applicability and significance in the clinical world was reinforced by resident revelations during discussion periods. Uniformly, anesthesiology trainees said it is much more difficult, psychologically, to challenge the directives or actions of attending faculty physicians, and in particular one’s own attending faculty (ie, it is hard to speak up to senior anesthesiologists and surgeons, and it is even harder to speak up toward an anesthesiologist than toward a surgeon).
Conversely, challenges made toward nurses were not meaningfully improved by this training. Many residents did not recognize some opportunities for challenging nurses, which may reflect a perceived diminished role for the nurse in critical events. It concerns us that this may mirror a clinical problem where anesthesia trainees may not fully appreciate the important role that a skilled circulating nurse can play in a critical event by managing available resources and providing clinical expertise.
That postintervention scores were not even higher was a surprise to us, particularly since participants were told explicitly that the second scenario would offer opportunities to practice language for challenging. There are several probable reasons to account for less-than-perfect challenging during the second scenario: (1) the opportunities for challenge were purposely designed to be “gray” rather than “black and white.” We sought to design conditions in which an earnest discussion would be warranted; we tried to not create scenarios where the confederate was obviously wrong, so that speaking up would be a “no brainer”; (2) speaking up across authority gradients is clearly a difficult skill that requires on-going work to overcome deeply ingrained barriers; (3) as confirmed by participants’ comments during debriefings, the scenarios were very realistic and engaging; challenging others became more difficult when they felt a sense of time urgency in managing evolving and critical clinical problems; and (4) as revealed by participants’ comments during debriefings, some of the events were not recognized as opportunities for challenge (eg, the nurse announcing he would be leaving the operating room, just as the patient became unstable).
There are a number of attributes of this study that qualify its conclusions and limit its generalizability. First, the simulated environment may not fully capture the behavior that would occur in the real clinical environment. This may be especially true when issues of patient safety arise as the subject knows that no real patient harm is possible. This limitation is inherent to a simulation setting. Second, the conversational skills taught in this study were measured very shortly after the educational experience. No attempt was made to measure retention or even application in subsequent real situations. Third, the particular issues that were integrated into the clinical cases and deemed to be controversial by the investigators may not, in the informed opinion of the subjects, be contraindicated. Of necessity, issues were chosen that were not so blatantly incorrect that they could be perceived as unrealistic. Finally, although the investigators believe intuitively and based on research in other domains that the two-challenge rule using the pairing advocacy and inquiry is an effective conversational tool to “speak up” when patient safety concerns arise, there was no attempt in this study to show that this method improves patient safety in the real clinical setting.
Although it is widely recognized that clinical knowledge and procedural skills can be taught effectively, it is less appreciated that collaborative language can be taught as well. We demonstrate that with a fully simulated operating room, and a debriefing intervention focused on “speaking up” against authority gradients, many trainees were able to learn and practice improved language patterns in a short period of time. Realizing that meaningful discussion is a “two-way street,” we have started to incorporate principles of the two-challenge rule and advocacy-inquiry into the simulation courses offered to our faculty. We have explicitly informed our anesthesiology faculty that the trainees are being taught this type of language so that they can more readily recognize and respond to these important messages in real clinical settings. Ultimately, a culture that not only tolerates but also encourages “speaking up” will enhance learning opportunities and promote improved interdisciplinary teamwork and patient safety.37
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